Laser Phototherapy (780 nm), a New Modality in Treatment of Long-Term Incomplete Peripheral Nerve Injury: A Randomized Double-Blind Placebo-Controlled Study

Abstract INTRODUCTION Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve postamputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective 1-yr follow-up to assess durability of pain relief and functional improvements. METHODS Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve post-amputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clinically and statistically significant improvements in pain and pain interference with PNS compared to placebo (Gilmore et al, 2019). This work presents prospective one-year follow-up to assess durability of pain relief and functional improvements. RESULTS A significantly greater proportion of subjects who completed the 12-mo visit reported = 50% pain relief on the BPI-SF (5/8, 63%; average pain relief = 73% among responders) compared to the placebo group at the time of crossover (0/14, 0%, P = .003; average pain relief = 23%). A majority of subjects also reported = 50% reductions in pain interference at 12 mo (5/8, 63%). Two of 13 (15%) subjects in the placebo group reported sustained improvements in pain interference (P = .06). Average reduction in pain interference among responders in the PNS group was 87%. CONCLUSION This work suggests that PNS delivered over 60 d may provide clinically significant and enduring pain relief, enabling improved function and potentially reducing the need for a permanently implanted system.

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Long-Term Antibiotic Treatment of Children with Secretory Otitis Media: A Double-Blind Placebo-Controlled Study

Acta Oto-Laryngologica ◽

10.3109/00016488809106373 ◽

1988 ◽

Vol 105 (sup449) ◽

pp. 49-50 ◽

Cited By ~ 4

Author(s):

J. Thomsen ◽

J. Sederberg-Olsen ◽

S. E. Stangerup ◽

V. Balle ◽

R. Vejlsgaard

Keyword(s):

Otitis Media ◽

Antibiotic Treatment ◽

Controlled Study ◽

Secretory Otitis Media ◽

Double Blind ◽

Double Blind Placebo

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Double blind, placebo-controlled study of long-term intermittent dobutamine infusion with concomitant oral amiodarone for end stage heart failure

Journal of the American College of Cardiology ◽

10.1016/s0735-1097(03)81800-4 ◽

2003 ◽

Vol 41 (6) ◽

pp. 162-163

Author(s):

Eleftheria Tsagalou ◽

Maria Anastasiou-Nana ◽

George Alexopoulos ◽

John Terrovitis ◽

Konstantinos Chalkias ◽

...

Keyword(s):

Heart Failure ◽

Dobutamine Infusion ◽

Controlled Study ◽

Double Blind ◽

Double Blind Placebo ◽

End Stage Heart Failure ◽

End Stage

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Long-Term Survival Is Comparable between Palifermin-Treated and Placebo-Treated Patients (Pts) with Hematologic Malignancies (HM) Undergoing High-Dose Chemotherapy and Total Body Irradiation Followed by Autologous Hematopoietic Stem Cell Transplantation (HSCT).

Blood ◽

10.1182/blood.v106.11.2925.2925 ◽

2005 ◽

Vol 106 (11) ◽

pp. 2925-2925 ◽

Cited By ~ 1

Author(s):

Ricardo Spielberger ◽

Christos Emmanouilides ◽

William Bensinger ◽

Alan Rong ◽

Alessandra Cesano ◽

...

Keyword(s):

Controlled Study ◽

Secondary Malignancies ◽

Double Blind ◽

Term Survival ◽

Hematopoietic Stem ◽

Double Blind Placebo ◽

Disease Outcomes ◽

Long Term Follow Up

Abstract Oral mucositis (OM) is a severely debilitating side effect of chemoradiotherapy that often causes significant pain, diminished quality of life, and increased risk of infections. Palifermin decreases the incidence and duration of severe OM in HM pts receiving myelotoxic therapy and HSCT. Palifermin safety and efficacy have not been established in the non-HM setting. Since the rHuKGF receptor is not expressed by HM, palifermin is not expected to interfere with long-term disease outcomes in this pt population. Aim: We assessed palifermin’s effects on the long-term disease outcomes (survival, disease progression, secondary malignancies) in pts with HM. Methods: Long-term follow-up data were pooled from a 1998 phase 2, double-blind, placebo-controlled study (n=86) and a 2000 double-blind, placebo-controlled phase 3 study (n=212). The analysis included 152 pts treated with palifermin and 146 pts treated with placebo. Pts were assessed at 6-month intervals during the first year and annually thereafter until death or loss to follow-up. The Kaplan-Meier (K–M) method provided estimates of the safety endpoints. Data reported here are as of August 2004. Results: There were 298 pts (152 palifermin: 146 placebo) monitored for long-term follow-up. The median follow-up period was 23.3 months for palifermin and 23.5 months for placebo. The overall survival and progression-free survival curves (p=0.474 and p=0.253, respectively) are similar between the palifermin and placebo groups. Secondary malignancies occurred in only 6 of 152 (3%) palifermin and 5 of 146 (4%) placebo pts. All secondary malignancies were myelodysplastic syndromes: 9 patients with diagnoses of Non-Hodgkin’s lymphoma and 2 patients of Hodgkin’s Disease. The number of deaths was similar between the groups (30% palifermin; 27% placebo); most deaths occurred within 12 months of randomization and were attributable to the underlying HM disease. Conclusion: Use of palifermin for the prevention of severe OM has shown no negative impact on long-term disease outcomes, including survival, in the HSCT setting for patients with HM.

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